A Single Oral Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Subjects Including a Single Intravenous Microdose of RO6836191
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 主要终点
- Part 2: Urine aldosterone levels
研究概览
简要总结
This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, aged 18 to 45 years old.
- •No active or chronic disease following a detailed medical and surgical history and complete physical examination.
- •A BMI between 18 to 30 kg/m2 inclusive.
- •Use of a highly effective form of birth control for the duration of the study and until 90 days after the last dose.
排除标准
- •Any clinically relevant current or history of conditions or illnesses.
- •Clinically significant symptoms of infection within 5 days of the first dosing day or a history of recurrent infections.
- •Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse.
- •Smokers unable or unwilling to restrict to 5 cigarettes daily during the study and to not smoke during the stay at the clinic.
- •Any cardiac abnormalities.
- •Blood donation over 450 mL within three months prior to screening.
- •Participation in an investigational drug or device study within 3 months prior to dosing.
- •Corticosteroid use within 3 months prior to dosing.
研究组 & 干预措施
Part 2: RO6836191: NS followed by LS diet
干预措施: NS followed by LS diet condition (Other)
Part 2: RO6836191: NS followed by LS diet
干预措施: RO6836191 (Drug)
Part 1: Single Ascending Doses (SAD) of RO6836191
干预措施: RO6836191 (Drug)
Part 1: Placebo (PL)
干预措施: Placebo (Drug)
Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet
干预措施: LS followed by NS diet condition (Other)
Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet
干预措施: Placebo (Drug)
Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet
干预措施: RO6836191 (Drug)
Part 2: PL: NS followed by LS diet
干预措施: NS followed by LS diet condition (Other)
Part 2: PL: NS followed by LS diet
干预措施: Placebo (Drug)
Part 2: PL: NS followed by LS diet
干预措施: RO6836191 (Drug)
Part 2: RO6836191: LS followed by NS diet
干预措施: LS followed by NS diet condition (Other)
Part 2: RO6836191: LS followed by NS diet
干预措施: RO6836191 (Drug)
结局指标
主要结局
Part 2: Urine aldosterone levels
时间窗: Up to 3 days after drug administration
Part 1: Plasma aldosterone levels
时间窗: Up to Day 5
Part 2: Incidence of AEs
时间窗: Up to 12 weeks
Parts 1: Incidence of adverse events (AE)
时间窗: Until Day 21
Part 1: Urine aldosterone levels
时间窗: Up to Day 3
Part 2: Area under the concentration-time curve (AUC)
时间窗: Up to Day 35
Part 2: Plasma aldosterone levels
时间窗: Up to 2 days after drug administration
次要结局
- Part 2: Volume of distribution after intravenous administration(Days 28-37)